Delaware | 22-0790350 | |||||||
(State or other jurisdiction of
incorporation or organization) |
(I.R.S Employer
Identification No.)
|
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Common Stock, $0.10 Par Value | BMY | New York Stock Exchange | ||||||
1.000% Notes due 2025 | BMY25 | New York Stock Exchange | ||||||
1.750% Notes due 2035 | BMY35 | New York Stock Exchange | ||||||
Bristol-Myers Squibb Contingent Value Rights | BMY RT | New York Stock Exchange | ||||||
Celgene Contingent Value Rights | CELG RT | New York Stock Exchange |
Large accelerated filer ☒
|
Accelerated filer ☐
|
Non-accelerated filer ☐
|
Smaller reporting company ☐
|
Emerging growth company ☐
|
PART I—FINANCIAL INFORMATION | |||||
Item 1. | |||||
Item 2. | |||||
Item 3. | |||||
Item 4. | |||||
PART II—OTHER INFORMATION | |||||
Item 1. | |||||
Item 1A. | |||||
Item 2. | |||||
Item 6. | |||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
EARNINGS | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Net product sales | $ | 10,197 | $ | 5,768 | $ | 30,555 | $ | 17,512 | |||||||||||||||
Alliance and other revenues | 343 | 239 | 895 | 688 | |||||||||||||||||||
Total Revenues | 10,540 | 6,007 | 31,450 | 18,200 | |||||||||||||||||||
Cost of products sold(a)
|
2,502 | 1,790 | 8,863 | 5,586 | |||||||||||||||||||
Marketing, selling and administrative | 1,706 | 1,055 | 4,940 | 3,137 | |||||||||||||||||||
Research and development | 2,499 | 1,378 | 7,393 | 4,051 | |||||||||||||||||||
Amortization of acquired intangible assets | 2,491 | 25 | 7,162 | 73 | |||||||||||||||||||
Other (income)/expense, net | (915) | 410 | (488) | 249 | |||||||||||||||||||
Total Expenses | 8,283 | 4,658 | 27,870 | 13,096 | |||||||||||||||||||
Earnings Before Income Taxes | 2,257 | 1,349 | 3,580 | 5,104 | |||||||||||||||||||
Provision/(Benefit) for Income Taxes | 379 | (17) | 2,548 | 584 | |||||||||||||||||||
Net Earnings | 1,878 | 1,366 | 1,032 | 4,520 | |||||||||||||||||||
Noncontrolling Interest | 6 | 13 | 20 | 25 | |||||||||||||||||||
Net Earnings Attributable to BMS | $ | 1,872 | $ | 1,353 | $ | 1,012 | $ | 4,495 | |||||||||||||||
Earnings per Common Share | |||||||||||||||||||||||
Basic | $ | 0.83 | $ | 0.83 | $ | 0.45 | $ | 2.75 | |||||||||||||||
Diluted | 0.82 | 0.83 | 0.44 | 2.75 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
COMPREHENSIVE INCOME | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Net Earnings | $ | 1,878 | $ | 1,366 | $ | 1,032 | $ | 4,520 | |||||||||||||||
Other Comprehensive (Loss)/Income, net of taxes and reclassifications to earnings: | |||||||||||||||||||||||
Derivatives qualifying as cash flow hedges | (132) | 38 | (121) | 24 | |||||||||||||||||||
Pension and postretirement benefits | (4) | 1,116 | 5 | 1,204 | |||||||||||||||||||
Available-for-sale debt securities | (2) | 4 | 7 | 43 | |||||||||||||||||||
Foreign currency translation | (5) | — | (70) | 28 | |||||||||||||||||||
Other Comprehensive (Loss)/Income | (143) | 1,158 | (179) | 1,299 | |||||||||||||||||||
Comprehensive Income | 1,735 | 2,524 | 853 | 5,819 | |||||||||||||||||||
Comprehensive Income Attributable to Noncontrolling Interest | 6 | 13 | 20 | 25 | |||||||||||||||||||
Comprehensive Income Attributable to BMS | $ | 1,729 | $ | 2,511 | $ | 833 | $ | 5,794 |
ASSETS |
September 30,
2020 |
December 31,
2019 |
|||||||||
Current Assets: | |||||||||||
Cash and cash equivalents | $ | 19,435 | $ | 12,346 | |||||||
Marketable debt securities | 1,720 | 3,047 | |||||||||
Receivables | 8,062 | 7,685 | |||||||||
Inventories | 1,949 | 4,293 | |||||||||
Other current assets | 3,111 | 1,983 | |||||||||
Total Current Assets | 34,277 | 29,354 | |||||||||
Property, plant and equipment | 5,740 | 6,252 | |||||||||
Goodwill | 20,517 | 22,488 | |||||||||
Other intangible assets | 56,698 | 63,969 | |||||||||
Deferred income taxes | 913 | 510 | |||||||||
Marketable debt securities | 495 | 767 | |||||||||
Other non-current assets | 6,896 | 6,604 | |||||||||
Total Assets | $ | 125,536 | $ | 129,944 | |||||||
LIABILITIES | |||||||||||
Current Liabilities: | |||||||||||
Short-term debt obligations | $ | 3,585 | $ | 3,346 | |||||||
Accounts payable | 2,441 | 2,445 | |||||||||
Other current liabilities | 14,438 | 12,513 | |||||||||
Total Current Liabilities | 20,464 | 18,304 | |||||||||
Deferred income taxes | 5,913 | 6,454 | |||||||||
Long-term debt | 41,364 | 43,387 | |||||||||
Other non-current liabilities | 7,565 | 10,101 | |||||||||
Total Liabilities | 75,306 | 78,246 | |||||||||
Commitments and contingencies | |||||||||||
EQUITY | |||||||||||
Bristol-Myers Squibb Company Shareholders’ Equity: | |||||||||||
Preferred stock | — | — | |||||||||
Common stock | 292 | 292 | |||||||||
Capital in excess of par value of stock | 44,435 | 43,709 | |||||||||
Accumulated other comprehensive loss | (1,699) | (1,520) | |||||||||
Retained earnings | 32,414 | 34,474 | |||||||||
Less cost of treasury stock | (25,284) | (25,357) | |||||||||
Total Bristol-Myers Squibb Company Shareholders’ Equity | 50,158 | 51,598 | |||||||||
Noncontrolling interest | 72 | 100 | |||||||||
Total Equity | 50,230 | 51,698 | |||||||||
Total Liabilities and Equity | $ | 125,536 | $ | 129,944 |
Nine Months Ended September 30, | |||||||||||
2020 | 2019 | ||||||||||
Cash Flows From Operating Activities: | |||||||||||
Net earnings | $ | 1,032 | $ | 4,520 | |||||||
Adjustments to reconcile net earnings to net cash provided by operating activities: | |||||||||||
Depreciation and amortization, net | 7,690 | 510 | |||||||||
Deferred income taxes | 1,419 | (536) | |||||||||
Stock-based compensation | 608 | 157 | |||||||||
Impairment charges | 131 | 183 | |||||||||
Pension settlements and amortization | 34 | 1,683 | |||||||||
Divestiture gains and royalties | (486) | (1,676) | |||||||||
Asset acquisition charges | 278 | 25 | |||||||||
Equity investment (gains)/losses | (724) | 15 | |||||||||
Contingent consideration fair value adjustments | (597) | — | |||||||||
Other adjustments | (140) | (21) | |||||||||
Changes in operating assets and liabilities: | |||||||||||
Receivables | (356) | 434 | |||||||||
Inventories | 2,571 | (7) | |||||||||
Accounts payable | 56 | 48 | |||||||||
Income taxes payable | (2,104) | (4) | |||||||||
Other | 970 | 698 | |||||||||
Net Cash Provided by Operating Activities | 10,382 | 6,029 | |||||||||
Cash Flows From Investing Activities: | |||||||||||
Sale and maturities of marketable debt securities | 4,757 | 2,325 | |||||||||
Purchase of marketable debt securities | (3,148) | (1,642) | |||||||||
Capital expenditures | (470) | (585) | |||||||||
Divestiture and other proceeds | 550 | 2,226 | |||||||||
Acquisition and other payments, net of cash acquired | (421) | (58) | |||||||||
Net Cash Provided by Investing Activities | 1,268 | 2,266 | |||||||||
Cash Flows From Financing Activities: | |||||||||||
Short-term debt obligations, net | (264) | 115 | |||||||||
Issuance of long-term debt | — | 18,790 | |||||||||
Repayment of long-term debt | (1,500) | (1,256) | |||||||||
Repurchase of common stock | (81) | (300) | |||||||||
Dividends | (3,054) | (2,011) | |||||||||
Other | 265 | (40) | |||||||||
Net Cash (Used in)/Provided by Financing Activities | (4,634) | 15,298 | |||||||||
Effect of Exchange Rates on Cash, Cash Equivalents and Restricted Cash | 24 | (15) | |||||||||
Increase in Cash, Cash Equivalents and Restricted Cash | 7,040 | 23,578 | |||||||||
Cash, Cash Equivalents and Restricted Cash at Beginning of Period | 12,820 | 6,911 | |||||||||
Cash, Cash Equivalents and Restricted Cash at End of Period | $ | 19,860 | $ | 30,489 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Net product sales | $ | 10,197 | $ | 5,768 | $ | 30,555 | $ | 17,512 | |||||||||||||||
Alliance revenues | 184 | 143 | 452 | 418 | |||||||||||||||||||
Other revenues | 159 | 96 | 443 | 270 | |||||||||||||||||||
Total Revenues | $ | 10,540 | $ | 6,007 | $ | 31,450 | $ | 18,200 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Gross product sales | $ | 15,211 | $ | 8,884 | $ | 43,685 | $ | 25,697 | |||||||||||||||
GTN adjustments(a)
|
|||||||||||||||||||||||
Charge-backs and cash discounts | (1,440) | (927) | (4,072) | (2,591) | |||||||||||||||||||
Medicaid and Medicare rebates | (2,146) | (1,362) | (5,126) | (3,252) | |||||||||||||||||||
Other rebates, returns, discounts and adjustments | (1,428) | (827) | (3,932) | (2,342) | |||||||||||||||||||
Total GTN adjustments | (5,014) | (3,116) | (13,130) | (8,185) | |||||||||||||||||||
Net product sales | $ | 10,197 | $ | 5,768 | $ | 30,555 | $ | 17,512 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Prioritized Brands | |||||||||||||||||||||||
Revlimid | $ | 3,027 | $ | — | $ | 8,826 | $ | — | |||||||||||||||
Eliquis | 2,095 | 1,928 | 6,899 | 5,895 | |||||||||||||||||||
Opdivo | 1,780 | 1,817 | 5,199 | 5,441 | |||||||||||||||||||
Orencia | 826 | 767 | 2,290 | 2,185 | |||||||||||||||||||
Pomalyst/Imnovid | 777 | — | 2,235 | — | |||||||||||||||||||
Sprycel | 544 | 558 | 1,576 | 1,561 | |||||||||||||||||||
Yervoy | 446 | 353 | 1,211 | 1,104 | |||||||||||||||||||
Abraxane | 342 | — | 950 | — | |||||||||||||||||||
Empliciti | 96 | 89 | 290 | 263 | |||||||||||||||||||
Reblozyl | 96 | — | 159 | — | |||||||||||||||||||
Inrebic | 13 | — | 40 | — | |||||||||||||||||||
Zeposia | 2 | — | 3 | — | |||||||||||||||||||
Onureg | 3 | — | 3 | — | |||||||||||||||||||
Established Brands | |||||||||||||||||||||||
Baraclude | 100 | 145 | 343 | 433 | |||||||||||||||||||
Vidaza | 106 | — | 390 | — | |||||||||||||||||||
Other Brands(a)
|
287 | 350 | 1,036 | 1,318 | |||||||||||||||||||
Total Revenues | $ | 10,540 | $ | 6,007 | $ | 31,450 | $ | 18,200 | |||||||||||||||
United States | $ | 6,542 | $ | 3,472 | $ | 19,795 | $ | 10,588 | |||||||||||||||
Europe | 2,453 | 1,445 | 7,156 | 4,416 | |||||||||||||||||||
Rest of the World | 1,361 | 976 | 4,030 | 2,838 | |||||||||||||||||||
Other(b)
|
184 | 114 | 469 | 358 | |||||||||||||||||||
Total Revenues | $ | 10,540 | $ | 6,007 | $ | 31,450 | $ | 18,200 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Revenues from alliances: | |||||||||||||||||||||||
Net product sales | $ | 2,116 | $ | 2,464 | $ | 7,040 | $ | 7,412 | |||||||||||||||
Alliance revenues | 184 | 143 | 452 | 418 | |||||||||||||||||||
Total Revenues | $ | 2,300 | $ | 2,607 | $ | 7,492 | $ | 7,830 | |||||||||||||||
Payments to/(from) alliance partners: | |||||||||||||||||||||||
Cost of products sold | $ | 1,007 | $ | 1,017 | $ | 3,363 | $ | 3,116 | |||||||||||||||
Marketing, selling and administrative | (25) | (33) | (103) | (93) | |||||||||||||||||||
Research and development | 48 | 11 | 327 | 32 | |||||||||||||||||||
Other (income)/expense, net | (28) | (15) | (59) | (45) |
Dollars in Millions |
September 30,
2020 |
December 31,
2019 |
|||||||||
Selected Alliance Balance Sheet information: | |||||||||||
Receivables – from alliance partners | $ | 336 | $ | 347 | |||||||
Accounts payable – to alliance partners | 971 | 1,026 | |||||||||
Deferred income from alliances(a)
|
392 | 431 |
Dollars in Millions |
Amounts Recognized as of Acquisition Date
(as previously reported) |
Measurement Period Adjustments |
Amounts Recognized as of Acquisition Date
(as adjusted) |
||||||||||||||||||||||||||
Cash and cash equivalents | $ | 11,179 | $ | — | $ | 11,179 | |||||||||||||||||||||||
Receivables | 2,652 | — | 2,652 | ||||||||||||||||||||||||||
Inventories | 4,511 | — | 4,511 | ||||||||||||||||||||||||||
Property, plant and equipment | 1,342 | (277) | 1,065 | ||||||||||||||||||||||||||
Intangible assets | 64,027 | (100) | 63,927 | ||||||||||||||||||||||||||
Otezla* assets held-for-sale
|
13,400 | — | 13,400 | ||||||||||||||||||||||||||
Other assets | 3,408 | 45 | 3,453 | ||||||||||||||||||||||||||
Accounts payable | (363) | — | (363) | ||||||||||||||||||||||||||
Income taxes payable | (2,718) | (47) | (2,765) | ||||||||||||||||||||||||||
Deferred income tax liabilities | (7,339) | 2,350 | (4,989) | ||||||||||||||||||||||||||
Debt | (21,782) | — | (21,782) | ||||||||||||||||||||||||||
Other liabilities | (4,017) | 15 | (4,002) | ||||||||||||||||||||||||||
Identifiable net assets acquired | 64,300 | 1,986 | 66,286 | ||||||||||||||||||||||||||
Goodwill | 15,969 | (1,986) | 13,983 | ||||||||||||||||||||||||||
Total consideration transferred | $ | 80,269 | $ | — | $ | 80,269 |
Three Months Ended September 30, | |||||||||||||||||||||||||||||||||||
Net Proceeds(a)
|
Divestiture (Gains)/Losses | Royalty and Milestone Income | |||||||||||||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||||||||||||
UPSA Business | $ | — | $ | 1,510 | $ | — | $ | (1,176) | $ | — | $ | — | |||||||||||||||||||||||
Diabetes Business | 129 | 163 | — | — | (148) | (171) | |||||||||||||||||||||||||||||
Erbitux* | 3 | 3 | — | — | — | — | |||||||||||||||||||||||||||||
Manufacturing Operations | — | — | — | 1 | — | — | |||||||||||||||||||||||||||||
Mature Brands and Other | 41 | 7 | 1 | (4) | (44) | (6) | |||||||||||||||||||||||||||||
Total | $ | 173 | $ | 1,683 | $ | 1 | $ | (1,179) | $ | (192) | $ | (177) |
Nine Months Ended September 30, | |||||||||||||||||||||||||||||||||||
Net Proceeds(a)
|
Divestiture (Gains)/Losses | Royalty and Milestone Income | |||||||||||||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||||||||||||
UPSA Business | $ | — | $ | 1,510 | $ | — | $ | (1,160) | $ | — | $ | — | |||||||||||||||||||||||
Diabetes Business | 409 | 491 | — | — | (404) | (497) | |||||||||||||||||||||||||||||
Erbitux* | 10 | 11 | — | — | — | — | |||||||||||||||||||||||||||||
Manufacturing Operations | 10 | 3 | (1) | 1 | — | — | |||||||||||||||||||||||||||||
Plavix* and Avapro*/Avalide*
|
7 | — | (12) | — | — | — | |||||||||||||||||||||||||||||
Mature Brands and Other | 73 | 9 | 7 | (12) | (76) | (8) | |||||||||||||||||||||||||||||
Total | $ | 509 | $ | 2,024 | $ | (6) | $ | (1,171) | $ | (480) | $ | (505) |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Keytruda* royalties
|
$ | (176) | $ | (132) | $ | (492) | $ | (373) | |||||||||||||||
Up-front licensing fees | — | (24) | (30) | (24) | |||||||||||||||||||
Contingent milestone income | (16) | (6) | (62) | (15) | |||||||||||||||||||
Amortization of deferred income | (14) | (14) | (44) | (44) | |||||||||||||||||||
Other royalties | (5) | (3) | (16) | (6) | |||||||||||||||||||
Total | $ | (211) | $ | (179) | $ | (644) | $ | (462) |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Interest expense | $ | 346 | $ | 209 | $ | 1,065 | $ | 377 | |||||||||||||||
Pension and postretirement | — | 1,537 | (6) | 1,607 | |||||||||||||||||||
Royalties and licensing income | (403) | (356) | (1,124) | (967) | |||||||||||||||||||
Divestiture losses/(gains) | 1 | (1,179) | (6) | (1,171) | |||||||||||||||||||
Acquisition expenses | — | 7 | — | 475 | |||||||||||||||||||
Contingent consideration | (988) | — | (597) | — | |||||||||||||||||||
Investment income | (13) | (173) | (99) | (348) | |||||||||||||||||||
Integration expenses | 195 | 96 | 535 | 224 | |||||||||||||||||||
Provision for restructuring | 176 | 10 | 451 | 32 | |||||||||||||||||||
Equity investment (gains)/losses | (244) | 261 | (724) | 15 | |||||||||||||||||||
Litigation and other settlements | 10 | (1) | 41 | — | |||||||||||||||||||
Transition and other service fees | (18) | (7) | (129) | (11) | |||||||||||||||||||
Intangible asset impairment | — | — | 21 | 15 | |||||||||||||||||||
Reversion excise tax | — | — | 76 | — | |||||||||||||||||||
Other | 23 | 6 | 8 | 1 | |||||||||||||||||||
Other (income)/expense, net | $ | (915) | $ | 410 | $ | (488) | $ | 249 |
Dollars in Millions |
Three Months Ended
September 30, 2020 |
Nine Months Ended
September 30, 2020 |
|||||||||
Employee termination costs | $ | 133 | $ | 386 | |||||||
Other termination costs | 36 | 42 | |||||||||
Provision for restructuring | 169 | 428 | |||||||||
Integration expenses | 195 | 535 | |||||||||
Accelerated depreciation | 6 | 6 | |||||||||
Asset impairments | 3 | 42 | |||||||||
Other | — | 3 | |||||||||
Total charges | $ | 373 | $ | 1,014 |
Dollars in Millions |
Three Months Ended
September 30, 2020 |
Nine Months Ended
September 30, 2020 |
|||||||||
Marketing, selling and administrative | $ | 6 | $ | 7 | |||||||
Research and development | 3 | 42 | |||||||||
Other (income)/expense, net | 364 | 965 | |||||||||
Total charges | $ | 373 | $ | 1,014 |
Dollars in Millions |
Nine Months Ended
September 30, 2020 |
||||
Liability at January 1 | $ | 77 | |||
Charges | 372 | ||||
Change in estimates | (8) | ||||
Provision for restructuring(a)
|
364 | ||||
Foreign currency translation and other | 2 | ||||
Payments | (255) | ||||
Liability at September 30 | $ | 188 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Employee termination costs | $ | — | $ | 4 | $ | 3 | $ | 11 | |||||||||||||||
Other termination costs | 7 | 6 | 20 | 21 | |||||||||||||||||||
Provision for restructuring | 7 | 10 | 23 | 32 | |||||||||||||||||||
Accelerated depreciation | 1 | 33 | 42 | 96 | |||||||||||||||||||
Asset impairments | 2 | 9 | 44 | 119 | |||||||||||||||||||
Other shutdown costs | — | — | 6 | — | |||||||||||||||||||
Total charges | $ | 10 | $ | 52 | $ | 115 | $ | 247 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Cost of products sold | $ | 3 | $ | 22 | $ | 30 | $ | 156 | |||||||||||||||
Marketing, selling and administrative | — | — | — | 1 | |||||||||||||||||||
Research and development | — | 20 | 56 | 58 | |||||||||||||||||||
Other (income)/expense, net | 7 | 10 | 29 | 32 | |||||||||||||||||||
Total charges | $ | 10 | $ | 52 | $ | 115 | $ | 247 |
Nine Months Ended September 30, | |||||||||||
Dollars in Millions | 2020 | 2019 | |||||||||
Liability at December 31 | $ | 23 | $ | 99 | |||||||
Cease-use liability reclassification | — | (3) | |||||||||
Liability at January 1 | 23 | 96 | |||||||||
Charges | 22 | 36 | |||||||||
Change in estimates | 1 | (4) | |||||||||
Provision for restructuring | 23 | 32 | |||||||||
Foreign currency translation and other | — | (1) | |||||||||
Payments | (40) | (98) | |||||||||
Liability at September 30 | $ | 6 | $ | 29 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Earnings Before Income Taxes | $ | 2,257 | $ | 1,349 | $ | 3,580 | $ | 5,104 | |||||||||||||||
Provision/(Benefit) for Income Taxes | 379 | (17) | 2,548 | 584 | |||||||||||||||||||
Effective Tax Rate | 16.8 | % | (1.3) | % | 71.2 | % | 11.4 | % |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Amounts in Millions, Except Per Share Data | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Net Earnings Attributable to BMS Used for Basic and Diluted EPS Calculation | $ | 1,872 | $ | 1,353 | $ | 1,012 | $ | 4,495 | |||||||||||||||
Weighted-Average Common Shares Outstanding – Basic | 2,257 | 1,632 | 2,260 | 1,634 | |||||||||||||||||||
Incremental Shares Attributable to Share-Based Compensation Plans | 33 | 2 | 35 | 2 | |||||||||||||||||||
Weighted-Average Common Shares Outstanding – Diluted | 2,290 | 1,634 | 2,295 | 1,636 | |||||||||||||||||||
Earnings per Common Share | |||||||||||||||||||||||
Basic | $ | 0.83 | $ | 0.83 | $ | 0.45 | $ | 2.75 | |||||||||||||||
Diluted | 0.82 | 0.83 | 0.44 | 2.75 | |||||||||||||||||||
September 30, 2020 | December 31, 2019 | ||||||||||||||||||||||||||||||||||
Dollars in Millions | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |||||||||||||||||||||||||||||
Cash and cash equivalents - money market and other securities | $ | — | $ | 17,075 | $ | — | $ | — | $ | 10,448 | $ | — | |||||||||||||||||||||||
Marketable debt securities: | |||||||||||||||||||||||||||||||||||
Certificates of deposit | — | 1,391 | — | — | 1,227 | — | |||||||||||||||||||||||||||||
Commercial paper | — | — | — | — | 1,093 | — | |||||||||||||||||||||||||||||
Corporate debt securities | — | 824 | — | — | 1,494 | — | |||||||||||||||||||||||||||||
Derivative assets | — | 74 | — | — | 140 | — | |||||||||||||||||||||||||||||
Equity investments | 2,927 | 134 | — | 2,020 | 175 | — | |||||||||||||||||||||||||||||
Derivative liabilities | — | (120) | — | — | (40) | — | |||||||||||||||||||||||||||||
Contingent consideration liability: | |||||||||||||||||||||||||||||||||||
Contingent value rights | 1,697 | — | — | 2,275 | — | — | |||||||||||||||||||||||||||||
Other acquisition related contingent consideration | — | — | 73 | — | — | 106 |
Ranges (weighted average) utilized as of: | |||||||||||
Inputs | September 30, 2020 | ||||||||||
Discount rate |
2.2% to 2.7% (2.4%)
|
||||||||||
Probability of payment |
0% to 80% (2.7%)
|
||||||||||
Projected year of payment for development and regulatory milestones |
2021 to 2025
|
||||||||||
Dollars in Millions | Nine Months Ended September 30, 2020 | ||||
Fair value as of January 1 | $ | 106 | |||
Changes in estimated fair value | (35) | ||||
Foreign exchange | 2 | ||||
Fair value as of September 30 | $ | 73 |
September 30, 2020 | December 31, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||
Dollars in Millions | Amortized Cost | Gross Unrealized | Amortized Cost | Gross Unrealized | |||||||||||||||||||||||||||||||||||||||||||
Gains | Losses | Fair Value | Gains | Losses | Fair Value | ||||||||||||||||||||||||||||||||||||||||||
Certificates of deposit | $ | 1,391 | $ | — | $ | — | $ | 1,391 | $ | 1,227 | $ | — | $ | — | $ | 1,227 | |||||||||||||||||||||||||||||||
Commercial paper | — | — | — | — | 1,093 | — | — | 1,093 | |||||||||||||||||||||||||||||||||||||||
Corporate debt securities | 807 | 17 | — | 824 | 1,487 | 8 | (1) | 1,494 | |||||||||||||||||||||||||||||||||||||||
Total available-for-sale debt securities(a)
|
$ | 2,198 | $ | 17 | $ | — | $ | 2,215 | $ | 3,807 | $ | 8 | $ | (1) | $ | 3,814 | |||||||||||||||||||||||||||||||
Equity investments | 3,061 | 2,195 | |||||||||||||||||||||||||||||||||||||||||||||
Total | $ | 5,276 | $ | 6,009 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Net gain/(loss) recognized | $ | 170 | $ | (235) | $ | 577 | $ | (81) | |||||||||||||||
Less: Net gain recognized for equity investments sold | — | — | — | 14 | |||||||||||||||||||
Net unrealized gain/(loss) on equity investments held | $ | 170 | $ | (235) | $ | 577 | $ | (95) |
Three Months Ended September 30, 2020 | Nine Months Ended September 30, 2020 | ||||||||||||||||||||||
Dollars in Millions | Cost of products sold | Other (income)/expense, net | Cost of products sold | Other (income)/expense, net | |||||||||||||||||||
Interest rate swap contracts | $ | — | $ | (7) | $ | — | $ | (21) | |||||||||||||||
Cross-currency interest rate swap contracts | — | (3) | — | (8) | |||||||||||||||||||
Foreign currency forward contracts | (5) | 14 | (63) | (41) | |||||||||||||||||||
Foreign currency zero-cost collar contracts | — | — | — | 1 |
Three Months Ended September 30, 2019 | Nine Months Ended September 30, 2019 | ||||||||||||||||||||||
Dollars in Millions | Cost of products sold | Other (income)/expense, net | Cost of products sold | Other (income)/expense, net | |||||||||||||||||||
Interest rate swap contracts | $ | — | $ | (6) | $ | — | $ | (18) | |||||||||||||||
Cross-currency interest rate swap contracts | — | (2) | — | (6) | |||||||||||||||||||
Foreign currency forward contracts | (20) | (9) | (76) | (11) | |||||||||||||||||||
Forward starting interest rate swap options | — | — | — | 35 | |||||||||||||||||||
Deal contingent forward starting interest rate swap | — | — | — | 240 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Derivatives qualifying as cash flow hedges | |||||||||||||||||||||||
Foreign currency forward contracts gain/(loss): | |||||||||||||||||||||||
Recognized in Other Comprehensive (Loss)/Income(a)
|
$ | (128) | $ | 63 | $ | (65) | $ | 102 | |||||||||||||||
Reclassified to Cost of products sold | (17) | (20) | (69) | (76) | |||||||||||||||||||
Derivatives qualifying as net investment hedges | |||||||||||||||||||||||
Cross-currency interest rate swap contracts gain/(loss): | |||||||||||||||||||||||
Recognized in Other Comprehensive (Loss)/Income | (11) | 2 | (1) | 4 | |||||||||||||||||||
Non-derivatives qualifying as net investment hedges | |||||||||||||||||||||||
Non-U.S. dollar borrowings gain/(loss): | |||||||||||||||||||||||
Recognized in Other Comprehensive (Loss)/Income | (39) | 41 | (51) | 43 | |||||||||||||||||||
Dollars in Millions |
September 30,
2020 |
December 31,
2019 |
|||||||||
Non-U.S. short-term borrowings | $ | 183 | $ | 351 | |||||||
Current portion of long-term debt | 3,250 | 2,763 | |||||||||
Other | 152 | 232 | |||||||||
Total | $ | 3,585 | $ | 3,346 |
Dollars in Millions |
September 30,
2020 |
December 31,
2019 |
|||||||||
Principal Value | $ | 42,896 | $ | 44,335 | |||||||
Adjustments to Principal Value: | |||||||||||
Fair value of interest rate swap contracts | 27 | 6 | |||||||||
Unamortized basis adjustment from swap terminations | 155 | 175 | |||||||||
Unamortized bond discounts and issuance costs | (256) | (280) | |||||||||
Unamortized purchase price adjustments of Celgene debt | 1,792 | 1,914 | |||||||||
Total | $ | 44,614 | $ | 46,150 | |||||||
Current portion of long-term debt | $ | 3,250 | $ | 2,763 | |||||||
Long-term debt | 41,364 | 43,387 | |||||||||
Total | $ | 44,614 | $ | 46,150 |
Dollars in Millions |
September 30,
2020 |
December 31,
2019 |
|||||||||
Trade receivables | $ | 7,168 | $ | 6,888 | |||||||
Less charge-backs and cash discounts | (371) | (391) | |||||||||
Less allowance for expected credit loss | (20) | (21) | |||||||||
Net trade receivables | 6,777 | 6,476 | |||||||||
Alliance, royalties, VAT and other | 1,285 | 1,209 | |||||||||
Receivables | $ | 8,062 | $ | 7,685 |
Dollars in Millions |
September 30,
2020 |
December 31,
2019 |
|||||||||
Finished goods | $ | 822 | $ | 2,227 | |||||||
Work in process | 2,069 | 3,267 | |||||||||
Raw and packaging materials | 221 | 172 | |||||||||
Total inventories | $ | 3,112 | $ | 5,666 | |||||||
Inventories | $ | 1,949 | $ | 4,293 | |||||||
Other non-current assets | 1,163 | 1,373 |
Dollars in Millions |
September 30,
2020 |
December 31,
2019 |
|||||||||
Land | $ | 188 | $ | 187 | |||||||
Buildings | 5,708 | 6,336 | |||||||||
Machinery, equipment and fixtures | 3,101 | 3,157 | |||||||||
Construction in progress | 409 | 527 | |||||||||
Gross property, plant and equipment | 9,406 | 10,207 | |||||||||
Less accumulated depreciation | (3,666) | (3,955) | |||||||||
Property, plant and equipment(a)
|
$ | 5,740 | $ | 6,252 |
Dollars in Millions | Estimated Useful Lives |
September 30,
2020 |
December 31,
2019 |
||||||||||||||
Goodwill(a)
|
$ | 20,517 | $ | 22,488 | |||||||||||||
Other intangible assets: | |||||||||||||||||
Licenses |
5 – 15 years
|
461 | 482 | ||||||||||||||
Acquired developed product rights(a)
|
3 – 15 years
|
59,651 | 46,827 | ||||||||||||||
Capitalized software |
3 – 10 years
|
1,357 | 1,297 | ||||||||||||||
IPRD | 6,600 | 19,500 | |||||||||||||||
Gross other intangible assets | 68,069 | 68,106 | |||||||||||||||
Less accumulated amortization | (11,371) | (4,137) | |||||||||||||||
Other intangible assets | $ | 56,698 | $ | 63,969 |
Dollars in Millions |
September 30,
2020 |
December 31, 2019 | |||||||||
Prepaid and refundable income taxes | $ | 1,633 | $ | 754 | |||||||
Research and development | 462 | 410 | |||||||||
Equity investments | 126 | — | |||||||||
Other(a)
|
890 | 819 | |||||||||
Other current assets | $ | 3,111 | $ | 1,983 |
Dollars in Millions |
September 30,
2020 |
December 31, 2019 | |||||||||
Equity investments | $ | 4,166 | $ | 3,405 | |||||||
Inventories | 1,163 | 1,373 | |||||||||
Operating leases | 718 | 704 | |||||||||
Pension and postretirement | 222 | 456 | |||||||||
Restricted cash(a)
|
341 | 390 | |||||||||
Other | 286 | 276 | |||||||||
Other non-current assets | $ | 6,896 | $ | 6,604 |
Dollars in Millions |
September 30,
2020 |
December 31, 2019 | |||||||||
Rebates and returns | $ | 5,747 | $ | 4,275 | |||||||
Income taxes payable | 686 | 1,517 | |||||||||
Employee compensation and benefits | 1,069 | 1,457 | |||||||||
Research and development | 1,315 | 1,324 | |||||||||
Dividends | 1,043 | 1,025 | |||||||||
Interest | 380 | 493 | |||||||||
Royalties | 398 | 418 | |||||||||
Operating leases | 136 | 133 | |||||||||
Contingent value rights | 1,680 | — | |||||||||
Other | 1,984 | 1,871 | |||||||||
Other current liabilities | $ | 14,438 | $ | 12,513 |
Dollars in Millions |
September 30,
2020 |
December 31, 2019 | |||||||||
Income taxes payable | $ | 5,025 | $ | 5,368 | |||||||
Contingent value rights | 17 | 2,275 | |||||||||
Pension and postretirement | 871 | 725 | |||||||||
Operating leases | 722 | 672 | |||||||||
Deferred income | 361 | 424 | |||||||||
Deferred compensation | 301 | 287 | |||||||||
Other | 268 | 350 | |||||||||
Other non-current liabilities | $ | 7,565 | $ | 10,101 |
Common Stock | Capital in Excess of Par Value of Stock | Accumulated Other Comprehensive Loss | Retained Earnings | Treasury Stock | Noncontrolling Interest | ||||||||||||||||||||||||||||||||||||||||||
Dollars and Shares in Millions | Shares | Par Value | Shares | Cost | |||||||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2019 | 2,923 | $ | 292 | $ | 43,709 | $ | (1,520) | $ | 34,474 | 672 | $ | (25,357) | $ | 100 | |||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | (775) | — | — | 9 | |||||||||||||||||||||||||||||||||||||||
Other Comprehensive Loss | — | — | — | (29) | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Cash dividends declared(a)
|
— | — | — | — | (1,028) | — | — | — | |||||||||||||||||||||||||||||||||||||||
Share repurchase program | — | — | — | — | — | 1 | (81) | — | |||||||||||||||||||||||||||||||||||||||
Stock compensation | — | — | (455) | — | — | (13) | 681 | — | |||||||||||||||||||||||||||||||||||||||
Distributions | — | — | — | — | — | — | — | (43) | |||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2020 | 2,923 | 292 | 43,254 | (1,549) | 32,671 | 660 | (24,757) | 66 | |||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | (85) | — | — | 5 | |||||||||||||||||||||||||||||||||||||||
Other Comprehensive Loss | — | — | — | (7) | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Cash dividends declared(a)
|
— | — | — | — | (1,021) | — | — | — | |||||||||||||||||||||||||||||||||||||||
Stock repurchase program | — | — | 1,400 | — | — | 16 | (1,400) | — | |||||||||||||||||||||||||||||||||||||||
Stock compensation | — | — | (210) | — | — | (7) | 506 | — | |||||||||||||||||||||||||||||||||||||||
Distributions | — | — | — | — | — | — | — | (5) | |||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2020 | 2,923 | 292 | 44,444 | (1,556) | 31,565 | 669 | (25,651) | 66 | |||||||||||||||||||||||||||||||||||||||
Net earnings | — | — | — | — | 1,872 | — | — | 6 | |||||||||||||||||||||||||||||||||||||||
Other Comprehensive Loss | — | — | — | (143) | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Cash dividends declared(a)
|
— | — | — | — | (1,023) | — | — | — | |||||||||||||||||||||||||||||||||||||||
Stock repurchase program | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Stock compensation | — | — | (9) | — | — | (6) | 367 | — | |||||||||||||||||||||||||||||||||||||||
Distributions | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2020 | 2,923 | $ | 292 | $ | 44,435 | $ | (1,699) | $ | 32,414 | 663 | $ | (25,284) | $ | 72 |
Common Stock | Capital in Excess of Par Value of Stock | Accumulated Other Comprehensive Loss | Retained Earnings | Treasury Stock | Noncontrolling Interest | ||||||||||||||||||||||||||||||||||||||||||
Dollars and Shares in Millions | Shares | Par Value | Shares | Cost | |||||||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2018 | 2,208 | $ | 221 | $ | 2,081 | $ | (2,762) | $ | 34,065 | 576 | $ | (19,574) | $ | 96 | |||||||||||||||||||||||||||||||||
Accounting change - cumulative effect(a)
|
— | — | — | — | 5 | — | — | — | |||||||||||||||||||||||||||||||||||||||
Adjusted balance at January 1, 2019 | 2,208 | 221 | 2,081 | (2,762) | 34,070 | 576 | (19,574) | 96 | |||||||||||||||||||||||||||||||||||||||
Net earnings | — | — | — | — | 1,710 | — | — | 5 | |||||||||||||||||||||||||||||||||||||||
Other Comprehensive Income | — | — | — | 118 | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Cash dividends declared(b)
|
— | — | — | — | (671) | — | — | — | |||||||||||||||||||||||||||||||||||||||
Stock compensation | — | — | 22 | — | — | (4) | 3 | — | |||||||||||||||||||||||||||||||||||||||
Distributions | — | — | — | — | — | — | — | (2) | |||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2019 | 2,208 | 221 | 2,103 | (2,644) | 35,109 | 572 | (19,571) | 99 | |||||||||||||||||||||||||||||||||||||||
Net earnings | — | — | — | — | 1,432 | — | — | 7 | |||||||||||||||||||||||||||||||||||||||
Other Comprehensive Income | — | — | — | 23 | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Cash dividends declared(b)
|
— | — | — | — | (671) | — | — | — | |||||||||||||||||||||||||||||||||||||||
Stock compensation | — | — | 47 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Distributions | — | — | — | — | — | — | — | (4) | |||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2019 | 2,208 | 221 | 2,150 | (2,621) | 35,870 | 572 | (19,571) | 102 | |||||||||||||||||||||||||||||||||||||||
Net earnings | — | — | — | — | 1,353 | — | — | 13 | |||||||||||||||||||||||||||||||||||||||
Other Comprehensive Income | — | — | — | 1,158 | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Cash dividends declared(b)
|
— | — | — | — | (668) | — | — | — | |||||||||||||||||||||||||||||||||||||||
Stock repurchase program | — | — | — | — | — | 7 | (300) | — | |||||||||||||||||||||||||||||||||||||||
Stock compensation | — | — | 56 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Distributions | — | — | — | — | — | — | — | (9) | |||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2019 | 2,208 | $ | 221 | $ | 2,206 | $ | (1,463) | $ | 36,555 | 579 | $ | (19,871) | $ | 106 |
2020 | 2019 | ||||||||||||||||||||||||||||||||||
Dollars in Millions | Pretax | Tax | After Tax | Pretax | Tax | After Tax | |||||||||||||||||||||||||||||
Three Months Ended September 30, | |||||||||||||||||||||||||||||||||||
Derivatives qualifying as cash flow hedges: | |||||||||||||||||||||||||||||||||||
Unrealized gain/(losses) | $ | (128) | $ | 10 | $ | (118) | $ | 63 | $ | (8) | $ | 55 | |||||||||||||||||||||||
Reclassified to net earnings(a)
|
(17) | 3 | (14) | (20) | 3 | (17) | |||||||||||||||||||||||||||||
Derivatives qualifying as cash flow hedges | (145) | 13 | (132) | 43 | (5) | 38 | |||||||||||||||||||||||||||||
Pension and postretirement benefits: | |||||||||||||||||||||||||||||||||||
Actuarial losses | (16) | 3 | (13) | (126) | 27 | (99) | |||||||||||||||||||||||||||||
Amortization(b)
|
9 | (2) | 7 | 12 | (2) | 10 | |||||||||||||||||||||||||||||
Settlements(b)
|
3 | (1) | 2 | 1,550 | (345) | 1,205 | |||||||||||||||||||||||||||||
Pension and postretirement benefits | (4) | — | (4) | 1,436 | (320) | 1,116 | |||||||||||||||||||||||||||||
Available-for-sale debt securities: | |||||||||||||||||||||||||||||||||||
Unrealized gains/(losses) | (4) | 2 | (2) | 6 | (2) | 4 | |||||||||||||||||||||||||||||
Foreign currency translation | (16) | 11 | (5) | 10 | (10) | — | |||||||||||||||||||||||||||||
Other Comprehensive (Loss)/Income | $ | (169) | $ | 26 | $ | (143) | $ | 1,495 | $ | (337) | $ | 1,158 | |||||||||||||||||||||||
Nine Months Ended September 30, | |||||||||||||||||||||||||||||||||||
Derivatives qualifying as cash flow hedges: | |||||||||||||||||||||||||||||||||||
Unrealized gains/(losses) | $ | (65) | $ | 4 | $ | (61) | $ | 102 | $ | (12) | $ | 90 | |||||||||||||||||||||||
Reclassified to net earnings(a)
|
(69) | 9 | (60) | (76) | 10 | (66) | |||||||||||||||||||||||||||||
Derivatives qualifying as cash flow hedges | (134) | 13 | (121) | 26 | (2) | 24 | |||||||||||||||||||||||||||||
Pension and postretirement benefits: | |||||||||||||||||||||||||||||||||||
Actuarial losses | (28) | 6 | (22) | (140) | 30 | (110) | |||||||||||||||||||||||||||||
Amortization(b)
|
27 | (5) | 22 | 45 | (8) | 37 | |||||||||||||||||||||||||||||
Settlements(b)
|
7 | (2) | 5 | 1,643 | (366) | 1,277 | |||||||||||||||||||||||||||||
Pension and postretirement benefits | 6 | (1) | 5 | 1,548 | (344) | 1,204 | |||||||||||||||||||||||||||||
Available-for-sale securities: | |||||||||||||||||||||||||||||||||||
Unrealized gains | 10 | (2) | 8 | 42 | (2) | 40 | |||||||||||||||||||||||||||||
Realized gains/(losses) | (1) | — | (1) | 3 | — | 3 | |||||||||||||||||||||||||||||
Available-for-sale securities | 9 | (2) | 7 | 45 | (2) | 43 | |||||||||||||||||||||||||||||
Foreign currency translation | (81) | 11 | (70) | 39 | (11) | 28 | |||||||||||||||||||||||||||||
Total Other Comprehensive (Loss)/Income | $ | (200) | $ | 21 | $ | (179) | $ | 1,658 | $ | (359) | $ | 1,299 |
Dollars in Millions |
September 30,
2020 |
December 31,
2019 |
|||||||||
Derivatives qualifying as cash flow hedges | $ | (102) | $ | 19 | |||||||
Pension and postretirement benefits | (894) | (899) | |||||||||
Available-for-sale debt securities | 13 | 6 | |||||||||
Foreign currency translation | (716) | (646) | |||||||||
Accumulated other comprehensive loss | $ | (1,699) | $ | (1,520) |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Service cost – benefits earned during the year | $ | 12 | $ | 6 | $ | 36 | $ | 18 | |||||||||||||||
Interest cost on projected benefit obligation | 11 | 20 | 30 | 101 | |||||||||||||||||||
Expected return on plan assets | (26) | (39) | (73) | (173) | |||||||||||||||||||
Amortization of prior service credits | (1) | (1) | (3) | (3) | |||||||||||||||||||
Amortization of net actuarial loss | 12 | 14 | 33 | 49 | |||||||||||||||||||
Curtailments and settlements | 3 | 1,550 | 7 | 1,643 | |||||||||||||||||||
Net periodic pension benefit cost | $ | 11 | $ | 1,550 | $ | 30 | $ | 1,635 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Cost of products sold | $ | 9 | $ | 4 | $ | 28 | $ | 11 | |||||||||||||||
Marketing, selling and administrative | 81 | 32 | 255 | 90 | |||||||||||||||||||
Research and development | 78 | 20 | 261 | 56 | |||||||||||||||||||
Other (income)/expense, net | 17 | — | 64 | — | |||||||||||||||||||
Total stock-based compensation expense | $ | 185 | $ | 56 | $ | 608 | $ | 157 | |||||||||||||||
Income tax benefit(a)
|
$ | 38 | $ | 10 | $ | 124 | $ | 29 |
Units in Millions | Units | Weighted-Average Fair Value | |||||||||
Restricted stock units | 13.0 | $ | 53.62 | ||||||||
Market share units | 0.9 | 53.92 | |||||||||
Performance share units | 1.4 | 55.61 |
Dollars in Millions | Stock Options | Restricted Stock Units | Market Share Units | Performance Share Units | |||||||||||||||||||
Unrecognized compensation cost | $ | 54 | $ | 991 | $ | 53 | $ | 93 | |||||||||||||||
Expected weighted-average period in years of compensation cost to be recognized | 1.5 | 2.6 | 3.0 | 1.8 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions, except per share data | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Total Revenues | $ | 10,540 | $ | 6,007 | $ | 31,450 | $ | 18,200 | |||||||||||||||
Diluted Earnings Per Share | |||||||||||||||||||||||
GAAP | $ | 0.82 | $ | 0.83 | $ | 0.44 | $ | 2.75 | |||||||||||||||
Non-GAAP | 1.63 | 1.17 | 4.98 | 3.46 | |||||||||||||||||||
Product | Date | Approval |
Opdivo+Yervoy | October 2020 |
FDA approval of Opdivo+Yervoy for the first-line treatment of adult patients with unresectable MPM.
|
Onureg | September 2020 |
FDA approval of Onureg (azacitidine) for the continued treatment of adult patients with AML who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
|
Reblozyl | June 2020 |
EC approval of Reblozyl for the treatment of adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk MDS with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy, or beta thalassemia.
|
Opdivo | June 2020 |
FDA approval of Opdivo for the treatment of patients with unresectable advanced, recurrent or metastic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy.
|
Zeposia | May 2020 |
EC approval of Zeposia for the treatment of adult patients with RRMS with active disease as defined by clinical or imaging features.
|
Opdivo+Yervoy | May 2020 |
FDA approval of Opdivo+Yervoy given with two cycles of platinum-doublet chemotherapy for the first-line treatment of adult patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations. The therapy is approved for patients with squamous or non-squamous disease and regardless of PD-L1 expression.
|
Opdivo+Yervoy | May 2020 |
FDA approval of Opdivo+Yervoy for the first-line treatment of adult patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations.
|
Pomalyst | May 2020 |
FDA approval of Pomalyst for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy, or in patients with Kaposi sarcoma who are HIV-negative.
|
Reblozyl | April 2020 |
FDA approval of Reblozyl for the treatment of anemia failing an erythropoiesis stimulating agent in adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require RBC transfusions.
|
Zeposia | March 2020 |
FDA approval of Zeposia (ozanimod) for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
|
Opdivo+Yervoy | March 2020 |
FDA approval of Opdivo+Yervoy combination for the treatment of HCC in patients who have been previously treated with sorafenib.
|
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | % Change |
Foreign Exchange(b)
|
2020 | 2019 | % Change |
Foreign Exchange(b)
|
|||||||||||||||||||||||||||||||||||||||
United States | $ | 6,542 | $ | 3,472 | 88 | % | — | $ | 19,795 | $ | 10,588 | 87 | % | — | |||||||||||||||||||||||||||||||||
Europe | 2,453 | 1,445 | 70 | % | 4 | % | 7,156 | 4,416 | 62 | % | (1) | % | |||||||||||||||||||||||||||||||||||
Rest of the World | 1,361 | 976 | 39 | % | (3) | % | 4,030 | 2,838 | 42 | % | (4) | % | |||||||||||||||||||||||||||||||||||
Other(a)
|
184 | 114 | 61 | % | N/A | 469 | 358 | 31 | % | N/A | |||||||||||||||||||||||||||||||||||||
Total | $ | 10,540 | $ | 6,007 | 75 | % | — | $ | 31,450 | $ | 18,200 | 73 | % | (1) | % |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | % Change | 2020 | 2019 | % Change | |||||||||||||||||||||||||||||
Gross product sales | $ | 15,211 | $ | 8,884 | 71 | % | $ | 43,685 | $ | 25,697 | 70 | % | |||||||||||||||||||||||
GTN adjustments | |||||||||||||||||||||||||||||||||||
Charge-backs and cash discounts | (1,440) | (927) | 55 | % | (4,072) | (2,591) | 57 | % | |||||||||||||||||||||||||||
Medicaid and Medicare rebates | (2,146) | (1,362) | 58 | % | (5,126) | (3,252) | 58 | % | |||||||||||||||||||||||||||
Other rebates, returns, discounts and adjustments | (1,428) | (827) | 73 | % | (3,932) | (2,342) | 68 | % | |||||||||||||||||||||||||||
Total GTN adjustments | (5,014) | (3,116) | 61 | % | (13,130) | (8,185) | 60 | % | |||||||||||||||||||||||||||
Net product sales | $ | 10,197 | $ | 5,768 | 77 | % | $ | 30,555 | $ | 17,512 | 74 | % | |||||||||||||||||||||||
GTN adjustments percentage | 33 | % | 35 | % | (2) | % | 30 | % | 32 | % | (2) | % | |||||||||||||||||||||||
U.S. | 39 | % | 44 | % | (5) | % | 36 | % | 40 | % | (4) | % | |||||||||||||||||||||||
Non-U.S. | 18 | % | 16 | % | 2 | % | 16 | % | 15 | % | 1 | % |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | % Change | 2020 | 2019 | % Change | |||||||||||||||||||||||||||||
Prioritized Brands | |||||||||||||||||||||||||||||||||||
Revlimid | $ | 3,027 | $ | — | N/A | $ | 8,826 | $ | — | N/A | |||||||||||||||||||||||||
U.S. | 2,080 | — | N/A | 6,094 | — | N/A | |||||||||||||||||||||||||||||
Non-U.S. | 947 | — | N/A | 2,732 | — | N/A | |||||||||||||||||||||||||||||
Eliquis | 2,095 | 1,928 | 9 | % | 6,899 | 5,895 | 17 | % | |||||||||||||||||||||||||||
U.S. | 1,118 | 1,124 | (1) | % | 4,258 | 3,599 | 18 | % | |||||||||||||||||||||||||||
Non-U.S. | 977 | 804 | 22 | % | 2,641 | 2,296 | 15 | % | |||||||||||||||||||||||||||
Opdivo | 1,780 | 1,817 | (2) | % | 5,199 | 5,441 | (4) | % | |||||||||||||||||||||||||||
U.S. | 1,018 | 1,088 | (6) | % | 2,982 | 3,324 | (10) | % | |||||||||||||||||||||||||||
Non-U.S. | 762 | 729 | 5 | % | 2,217 | 2,117 | 5 | % | |||||||||||||||||||||||||||
Orencia | 826 | 767 | 8 | % | 2,290 | 2,185 | 5 | % | |||||||||||||||||||||||||||
U.S. | 588 | 554 | 6 | % | 1,642 | 1,569 | 5 | % | |||||||||||||||||||||||||||
Non-U.S. | 238 | 213 | 12 | % | 648 | 616 | 5 | % | |||||||||||||||||||||||||||
Pomalyst/Imnovid | 777 | — | N/A | 2,235 | — | N/A | |||||||||||||||||||||||||||||
U.S. | 548 | — | N/A | 1,559 | — | N/A | |||||||||||||||||||||||||||||
Non-U.S. | 229 | — | N/A | 676 | — | N/A | |||||||||||||||||||||||||||||
Sprycel | 544 | 558 | (3) | % | 1,576 | 1,561 | 1 | % | |||||||||||||||||||||||||||
U.S. | 336 | 325 | 3 | % | 944 | 872 | 8 | % | |||||||||||||||||||||||||||
Non-U.S. | 208 | 233 | (11) | % | 632 | 689 | (8) | % | |||||||||||||||||||||||||||
Yervoy | 446 | 353 | 26 | % | 1,211 | 1,104 | 10 | % | |||||||||||||||||||||||||||
U.S. | 309 | 222 | 39 | % | 820 | 750 | 9 | % | |||||||||||||||||||||||||||
Non-U.S. | 137 | 131 | 5 | % | 391 | 354 | 10 | % | |||||||||||||||||||||||||||
Abraxane | 342 | — | N/A | 950 | — | N/A | |||||||||||||||||||||||||||||
U.S. | 236 | — | N/A | 659 | — | N/A | |||||||||||||||||||||||||||||
Non-U.S. | 106 | — | N/A | 291 | — | N/A | |||||||||||||||||||||||||||||
Empliciti | 96 | 89 | 8 | % | 290 | 263 | 10 | % | |||||||||||||||||||||||||||
U.S. | 59 | 62 | (5) | % | 177 | 183 | (3) | % | |||||||||||||||||||||||||||
Non-U.S. | 37 | 27 | 37 | % | 113 | 80 | 41 | % | |||||||||||||||||||||||||||
Reblozyl | 96 | — | N/A | 159 | — | N/A | |||||||||||||||||||||||||||||
U.S. | 92 | — | N/A | 155 | — | N/A | |||||||||||||||||||||||||||||
Non-U.S. | 4 | — | N/A | 4 | — | N/A | |||||||||||||||||||||||||||||
Inrebic | 13 | — | N/A | 40 | — | N/A | |||||||||||||||||||||||||||||
U.S. | 13 | — | N/A | 40 | — | N/A | |||||||||||||||||||||||||||||
Non-U.S. | — | — | N/A | — | — | N/A | |||||||||||||||||||||||||||||
Zeposia | 2 | — | N/A | 3 | — | N/A | |||||||||||||||||||||||||||||
U.S. | 2 | — | N/A | 3 | — | N/A | |||||||||||||||||||||||||||||
Non-U.S. | — | — | N/A | — | — | N/A | |||||||||||||||||||||||||||||
Onureg | 3 | — | N/A | 3 | — | N/A | |||||||||||||||||||||||||||||
U.S. | 3 | — | N/A | 3 | — | N/A | |||||||||||||||||||||||||||||
Non-U.S. | — | — | N/A | — | — | N/A |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | % Change | 2020 | 2019 | % Change | |||||||||||||||||||||||||||||
Established Brands | |||||||||||||||||||||||||||||||||||
Baraclude | 100 | 145 | (31) | % | 343 | 433 | (21) | % | |||||||||||||||||||||||||||
U.S. | 3 | 2 | 50 | % | 9 | 16 | (44) | % | |||||||||||||||||||||||||||
Non-U.S. | 97 | 143 | (32) | % | 334 | 417 | (20) | % | |||||||||||||||||||||||||||
Vidaza | 106 | — | N/A | 390 | — | N/A | |||||||||||||||||||||||||||||
U.S. | — | — | N/A | 2 | — | N/A | |||||||||||||||||||||||||||||
Non-U.S. | 106 | — | N/A | 388 | — | N/A | |||||||||||||||||||||||||||||
Other Brands(a)
|
287 | 350 | (18) | % | 1,036 | 1,318 | (21) | % | |||||||||||||||||||||||||||
U.S. | 137 | 95 | 44 | % | 448 | 275 | 63 | % | |||||||||||||||||||||||||||
Non-U.S. | 150 | 255 | (41) | % | 588 | 1,043 | (44) | % | |||||||||||||||||||||||||||
Total Revenues | 10,540 | 6,007 | 75 | % | 31,450 | 18,200 | 73 | % | |||||||||||||||||||||||||||
U.S. | 6,542 | 3,472 | 88 | % | 19,795 | 10,588 | 87 | % | |||||||||||||||||||||||||||
Non-U.S. | 3,998 | 2,535 | 58 | % | 11,655 | 7,612 | 53 | % |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | % Change | 2020 | 2019 | % Change | |||||||||||||||||||||||||||||
Cost of products sold(a)
|
$ | 2,502 | $ | 1,790 | 40 | % | $ | 8,863 | $ | 5,586 | 59 | % | |||||||||||||||||||||||
Marketing, selling and administrative | 1,706 | 1,055 | 62 | % | 4,940 | 3,137 | 57 | % | |||||||||||||||||||||||||||
Research and development | 2,499 | 1,378 | 81 | % | 7,393 | 4,051 | 82 | % | |||||||||||||||||||||||||||
Amortization of acquired intangible assets | 2,491 | 25 | ** | 7,162 | 73 | ** | |||||||||||||||||||||||||||||
Other (income)/expense, net | (915) | 410 | ** | (488) | 249 | ** | |||||||||||||||||||||||||||||
Total Expenses | $ | 8,283 | $ | 4,658 | 78 | % | $ | 27,870 | $ | 13,096 | ** |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Interest expense | $ | 346 | $ | 209 | $ | 1,065 | $ | 377 | |||||||||||||||
Pension and postretirement | — | 1,537 | (6) | 1,607 | |||||||||||||||||||
Royalties and licensing income | (403) | (356) | (1,124) | (967) | |||||||||||||||||||
Divestiture losses/(gains) | 1 | (1,179) | (6) | (1,171) | |||||||||||||||||||
Acquisition expenses | — | 7 | — | 475 | |||||||||||||||||||
Contingent consideration | (988) | — | (597) | — | |||||||||||||||||||
Investment income | (13) | (173) | (99) | (348) | |||||||||||||||||||
Integration expenses | 195 | 96 | 535 | 224 | |||||||||||||||||||
Provision for restructuring | 176 | 10 | 451 | 32 | |||||||||||||||||||
Equity investment (gains)/losses | (244) | 261 | (724) | 15 | |||||||||||||||||||
Litigation and other settlements | 10 | (1) | 41 | — | |||||||||||||||||||
Transition and other service fees | (18) | (7) | (129) | (11) | |||||||||||||||||||
Intangible asset impairment | — | — | 21 | 15 | |||||||||||||||||||
Reversion excise tax | — | — | 76 | — | |||||||||||||||||||
Other | 23 | 6 | 8 | 1 | |||||||||||||||||||
Other (income)/expense, net | $ | (915) | $ | 410 | $ | (488) | $ | 249 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Earnings Before Income Taxes | $ | 2,257 | $ | 1,349 | $ | 3,580 | $ | 5,104 | |||||||||||||||
Provision/(Benefit) for Income Taxes | 379 | (17) | 2,548 | 584 | |||||||||||||||||||
Effective Tax Rate | 16.8 | % | (1.3) | % | 71.2 | % | 11.4 | % | |||||||||||||||
Impact of Specified Items | (0.3) | % | (13.1) | % | 55.5 | % | (3.6) | % | |||||||||||||||
Effective Tax Rate Excluding Specified Items | 17.1 | % | 11.8 | % | 15.7 | % | 15.0 | % |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Inventory purchase price accounting adjustments | $ | 456 | $ | — | $ | 2,590 | $ | — | |||||||||||||||
Employee compensation charges | — | — | 3 | — | |||||||||||||||||||
Site exit and other costs | 3 | 22 | 32 | 173 | |||||||||||||||||||
Cost of products sold | 459 | 22 | 2,625 | 173 | |||||||||||||||||||
Employee compensation charges | 7 | — | 34 | — | |||||||||||||||||||
Site exit and other costs | (1) | — | 4 | 1 | |||||||||||||||||||
Marketing, selling and administrative | 6 | — | 38 | 1 | |||||||||||||||||||
License and asset acquisition charges | 203 | — | 528 | 25 | |||||||||||||||||||
IPRD impairments | — | — | — | 32 | |||||||||||||||||||
Inventory purchase price accounting adjustments | 8 | — | 25 | — | |||||||||||||||||||
Employee compensation charges | 8 | — | 41 | — | |||||||||||||||||||
Site exit and other costs | 4 | 20 | 99 | 58 | |||||||||||||||||||
Research and development | 223 | 20 | 693 | 115 | |||||||||||||||||||
Amortization of acquired intangible assets | 2,491 | — | 7,162 | — | |||||||||||||||||||
Interest expense(a)
|
(40) | 166 | (122) | 249 | |||||||||||||||||||
Pension and postretirement | — | 1,545 | — | 1,638 | |||||||||||||||||||
Royalties and licensing income | (53) | (9) | (154) | (9) | |||||||||||||||||||
Divestiture losses/(gains) | 1 | (1,179) | (6) | (1,171) | |||||||||||||||||||
Acquisition expenses | — | 7 | — | 475 | |||||||||||||||||||
Contingent consideration | (988) | — | (597) | — | |||||||||||||||||||
Investment income | — | (99) | — | (153) | |||||||||||||||||||
Integration expenses | 195 | 96 | 535 | 224 | |||||||||||||||||||
Provision for restructuring | 176 | 10 | 451 | 32 | |||||||||||||||||||
Equity investment (gains)/losses | (214) | 261 | (693) | 15 | |||||||||||||||||||
Reversion excise tax | — | — | 76 | — | |||||||||||||||||||
Other (income)/expense, net | (923) | 798 | (510) | 1,300 | |||||||||||||||||||
Increase to pretax income | 2,256 | 840 | 10,008 | 1,589 | |||||||||||||||||||
Income taxes on items above | (405) | (275) | (699) | (423) | |||||||||||||||||||
Income taxes attributed to Otezla* divestiture
|
11 | — | 266 | — | |||||||||||||||||||
Income taxes attributed to internal transfer of intangible assets | — | — | 853 | — | |||||||||||||||||||
Income taxes | (394) | (275) | 420 | (423) | |||||||||||||||||||
Increase to net earnings | $ | 1,862 | $ | 565 | $ | 10,428 | $ | 1,166 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
Dollars in Millions, except per share data | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
Net Earnings Attributable to BMS Used for Diluted EPS Calculation – GAAP | $ | 1,872 | $ | 1,353 | $ | 1,012 | $ | 4,495 | |||||||||||||||
Specified Items | 1,862 | 565 | 10,428 | 1,166 | |||||||||||||||||||
Net Earnings Attributable to BMS Used for Diluted EPS Calculation – Non-GAAP | $ | 3,734 | $ | 1,918 | $ | 11,440 | $ | 5,661 | |||||||||||||||
Weighted-Average Common Shares Outstanding – Diluted | 2,290 | 1,634 | 2,295 | 1,636 | |||||||||||||||||||
Diluted Earnings Per Share Attributable to BMS – GAAP | $ | 0.82 | $ | 0.83 | $ | 0.44 | $ | 2.75 | |||||||||||||||
Diluted EPS Attributable to Specified Items | 0.81 | 0.34 | 4.54 | 0.71 | |||||||||||||||||||
Diluted EPS Attributable to BMS – Non-GAAP | $ | 1.63 | $ | 1.17 | $ | 4.98 | $ | 3.46 |
Dollars in Millions |
September 30,
2020 |
December 31,
2019 |
|||||||||
Cash and cash equivalents | $ | 19,435 | $ | 12,346 | |||||||
Marketable debt securities – current | 1,720 | 3,047 | |||||||||
Marketable debt securities – non-current | 495 | 767 | |||||||||
Total cash, cash equivalents and marketable debt securities | 21,650 | 16,160 | |||||||||
Short-term debt obligations | (3,585) | (3,346) | |||||||||
Long-term debt | (41,364) | (43,387) | |||||||||
Net debt position | $ | (23,299) | $ | (30,573) |
Nine Months Ended September 30, | |||||||||||
Dollars in Millions | 2020 | 2019 | |||||||||
Cash flow provided by/(used in): | |||||||||||
Operating activities | $ | 10,382 | $ | 6,029 | |||||||
Investing activities | 1,268 | 2,266 | |||||||||
Financing activities | (4,634) | 15,298 |
Product | Indication | Date | Developments |
Opdivo | Bladder | September 2020 |
Announced that CheckMate-274, a pivotal Phase III trial evaluating Opdivo after surgery in patients with high-risk, muscle-invasive urothelial carcinoma, met its primary endpoints of improving disease-free survival versus placebo in both all randomized patients and in patients whose tumor cells express PD-L1 ≥1%.
|
||||||||
Gastric and Esophageal Cancers | October 2020 |
Announced that the CHMP of the EMA has recommended approval of Opdivo for the treatment of adults with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based combination chemotherapy.
|
|||||||||
September 2020 |
Ono, our alliance partner for Opdivo in Japan, announced that the results from Phase II/III clinical study evaluating Opdivo in combination with chemotherapy versus placebo in combination with chemotherapy in patients with unresectable advanced or recurrent gastric cancer who are negative for human epidermal growth factor receptor 2, and previously untreated with the first-line therapy in Japan, South Korea and Taiwan that the Opdivo combination group demonstrated a statistically significant improvement in one of the two primary endpoints of progression-free survival, but did not show a statistically significant improvement in overall survival, the other primary endpoint versus control combination group.
|
||||||||||
August 2020 |
Announced that CheckMate-649, a pivotal Phase III trial evaluating Opdivo plus chemotherapy compared to chemotherapy alone as a first-line treatment for metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, met both primary endpoints of overall survival at a pre-specified interim analysis and progression-free survival at final analysis in patients whose tumors express PD-L1 with a combined positive score ≥ 5. The overall survival benefit was also observed in the all-randomized population.
|
||||||||||
August 2020 |
Announced that the Phase III CheckMate-577 trial evaluating Opdivo as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction cancer met its primary endpoint of disease-free survival at a pre-specified interim analysis.
|
||||||||||
NSCLC | October 2020 | Announced that the Phase III CheckMate-816 trial met a primary endpoint of pathologic complete response in resectable NSCLC. | |||||||||
August 2020 |
Ono, our alliance partner for Opdivo in Japan, announced top-line results from the Phase III clinical study TASUKI-52 evaluating Opdivo in combination with bevacizumab and chemotherapy versus placebo in combination with bevacizumab and chemotherapy in chemotherapy-naive patients with stage IIIB/IV or recurrent non-squamous NSCLC. The Opdivo combination group demonstrated a statistically significant improvement in the primary endpoint of progression-free survival in a pre-specified interim analysis.
|
||||||||||
RCC | October 2020 |
Announced with Exelixis, that the FDA has accepted the sBLA and sNDA for Opdivo in combination with Cabometyx* for patients with advanced RCC. The FDA granted Priority Review to both applications and assigned a PDUFA goal date of February 20, 2021.
|
Product | Indication | Date | Developments |
Opdivo+Yervoy | CRC | September 2020 |
Ono, our alliance partner for Opdivo in Japan announced that the companies received approval for combination therapy of Opdivo and Yervoy in Japan to expand the combination use for the treatment of microsatellite instability high unresectable advanced or recurrent CRC that has progressed following chemotherapy, for a partial change in approved items of the manufacturing and marketing approval.
|
||||||||
RCC | September 2020 |
Announced that more than half of advanced RCC patients treated with the Opdivo plus Yervoy combination were alive after four years across the entire study population of the Phase III CheckMate-214 clinical trial, with the combination continuing to show superior, long-term overall survival and durable responses compared to sunitinib.
|
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NSCLC | September 2020 |
Announced that the CHMP of the EMA recommending approval of Opdivo plus Yervoy combined with two cycles of chemotherapy as first-line treatment of metastatic NSCLC in adults whose tumors have no sensitizing EGFR mutation or ALK translocation.
|
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MPM | October 2020 |
FDA approval of Opdivo+Yervoy for the first-line treatment of adult patients with unresectable MPM. This approval is based on a pre-specified interim analysis from the Phase III CheckMate-743 trial in which Opdivo+Yervoy demonstrated superior overall survival versus the platinum-based standard of care chemotherapy.
|
|||||||||
October 2020 |
Ono, our alliance partner for Opdivo in Japan announced that the companies have submitted supplemental applications in Japan for Opdivo and Yervoy in combination treatment to expand the use for first-line treatment of unresectable advanced or recurrent MPM, for a partial change in aprpoved items of the manufacturing and marketing approval.
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September 2020 |
Announced that the EMA validated the type II variation application for Opdivo plus Yervoy for treatment of patients with previously untreated, unresectable MPM.
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Melanoma | October 2020 |
Announced results for the co-primary endpoint for CheckMate-915, a randomized Phase III study evaluating Opdivo plus Yervoy versus Opdivo for patients who have had a complete surgical removal of stage IIIb/c/d or stage IV melanoma. The addition of Yervoy to Opdivo in this trial did not result in a statistically significant improvement in recurrence-free survival in the all-comer (intent-to-treat) population.
|
Zeposia | RMS | September 2020 |
Announced interim results from the Phase III open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia in patients with RMS. The trial included 2,494 patients who had previously completed a Phase I, II or III Zeposia clinical trial and who had an average treatment time of 35.4 months while in DAYBREAK and no new safety concerns emerged with long-term use of Zeposia.
|
Onureg | AML | September 2020 |
Announced FDA approval of Onureg (azacitidine) for the continued treatment of adult patients with AML who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
|
liso-cel | Lymphoma | July 2020 | Announced that the EMA validated the MAA for liso-cel, an investigational CD19-directed CAR T cell therapy, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade 3B after at least two prior therapies. |
ide-cel; bb2121 | Multiple Myeloma | September 2020 | Announced with bluebird bio that the FDA has accepted for Priority Review the BLA for ide-cel for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The FDA has set a PDUFA goal date of March 27, 2021. |
Deucravacitinib
(BMS-986165)
|
Plaque Psoriasis | November 2020 |
Announced results from Phase III POETYK PSO-1 trial evaluating deucravacitinib (BMS-986165), a novel, oral, selective tyrosine kinase 2 inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. POETYK PSO-1 evaluated 6 mg of deucravacitinib once daily and met both co-primary endpoints versus placebo, with more patients achieving Psoriasis Area and Severity Index (PASI) 75, defined as at least a 75 percent improvement in PASI, and a static Physician’s Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib. The trial also met multiple key secondary endpoints, including showing deucravacitinib was superior to Otezla* in the proportion of patients reaching a PASI 75 response and sPGA 0/1 at Week 16. The overall safety profile of deucravacitinib in the POETYK PSO-1 trial was consistent with previously reported Phase II results.
|
Idhifa | AML | August 2020 |
Announced that the Phase III IDHENTIFY study evaluating Idhifa plus best supportive care (BSC) versus conventional care regimens, which include BSC only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, did not meet the primary endpoint of overall survival in patients with relapsed or refractory AML with an isocitrate dehydrogenase-2 mutation.
|
Period |
Total Number of Shares Purchased(a)
|
Average Price Paid per Share(a)
|
Total Number of Shares Purchased as Part of Publicly Announced Programs(b)
|
Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs(b)
|
|||||||||||||||||||
Dollars in Millions, Except Per Share Data | |||||||||||||||||||||||
July 1 to 31, 2020 | 263,458 | $ | 59.03 | — | $ | 5,919 | |||||||||||||||||
August 1 to 31, 2020 | 98,881 | 60.18 | — | 5,919 | |||||||||||||||||||
September 1 to 30, 2020 | 76,308 | 61.05 | — | 5,919 | |||||||||||||||||||
Three months ended September 30, 2020 | 438,647 | — |
Exhibit No. | Description | |||||||
31a. | ||||||||
31b. | ||||||||
32a. | ||||||||
32b. | ||||||||
101.INS | XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | |||||||
101.SCH | XBRL Taxonomy Extension Schema Document. | |||||||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document. | |||||||
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document. | |||||||
101.LAB | XBRL Taxonomy Extension Label Linkbase Document. | |||||||
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document. | |||||||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
2019 Form 10-K | Annual Report on Form 10-K for the fiscal year ended December 31, 2019 | Lilly | Eli Lilly and Company | ||||||||
ALK | anaplastic lymphoma kinase | LOE | loss of exclusivity | ||||||||
Amgen | Amgen Inc. | MAA | market authorization application | ||||||||
AML | acute myeloid leukemia | MDL | multi-district litigation | ||||||||
Amylin | Amylin Pharmaceuticals, Inc. | MDS | myelodysplastic syndromes | ||||||||
aNDA | abbreviated new drug applications | MPM | malignant pleural mesothelioma | ||||||||
AstraZeneca | AstraZeneca PLC | MyoKardia | MyoKardia, Inc. | ||||||||
BCMA | B-cell maturation antigen | NDA | New drug application | ||||||||
Biohaven | Biohaven Pharmaceutical Holding Company Ltd. | NKT | natural killer T cells | ||||||||
BLA | biologics license application | NSCLC | non-small cell lung cancer | ||||||||
bluebird | bluebird bio, Inc. | NVAF | non-valvular atrial fibrillation | ||||||||
CAR T | chimeric antigen receptor T-cell | Ono | Ono Pharmaceutical Co., Ltd. | ||||||||
Catalent | Catalent, Inc. | ORR | overall response rate | ||||||||
Celgene | Celgene Corporation | OTC | over-the-counter | ||||||||
CERCLA | U.S. Comprehensive Environmental Response, Compensation and Liability Act | Otsuka | Otsuka Pharmaceutical Co., Ltd. | ||||||||
CML | chronic myeloid leukemia | PD-1 | programmed cell death protein 1 | ||||||||
CVR | contingent value rights | PD-L1 | programmed death-ligand 1 | ||||||||
Dragonfly | Dragonfly Therapeutics, Inc. | PDUFA | The Prescription Drug User Fee Act | ||||||||
EC | European Commission | Pfizer | Pfizer, Inc. | ||||||||
EGFR | estimated glomerular filtration rate | PsA | psoriatic arthritis | ||||||||
EMA | European Medicines Agency | Quarterly Report on Form 10-Q | Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 | ||||||||
EPS | earnings per share | R&D | research and development | ||||||||
ESCC | esophageal squamous cell carcinoma | RA | rheumatoid arthritis | ||||||||
EU | European Union | RCC | renal cell carcinoma | ||||||||
FASB | Financial Accounting Standards Board | Repare | Repare Therapeutics Inc. | ||||||||
FDA | U.S. Food and Drug Administration | RMS | relapsing forms of multiple sclerosis | ||||||||
Forbius | Forbius Biologics, Inc. | RRMM | relapsed and refractory multiple myeloma | ||||||||
GAAP | U.S. generally accepted accounting principles | RRMS | relapsing remitting multiple sclerosis | ||||||||
GTN | gross-to-net | Sanofi | Sanofi S.A. | ||||||||
HCC | hepatocellular carcinoma | SEC | Securities and Exchange Commission | ||||||||
HIV | human immunodeficiency viruses | UC | ulcerative colitis | ||||||||
IO | immuno-oncology | U.S. | United States | ||||||||
IPRD | in-process research and development | UK | United Kingdom | ||||||||
IRS | Internal Revenue Service | VAT | value added tax | ||||||||
JIA | juvenile idiopathic arthritis | ViiV | ViiV Healthcare Limited | ||||||||
LIBOR | London Interbank Offered Rate | VTE | venous thromboembolic |
BRISTOL-MYERS SQUIBB COMPANY
(REGISTRANT) |
|||||||||||
Date: | November 5, 2020 | By: | /s/ Giovanni Caforio, M.D. | ||||||||
Giovanni Caforio, M.D.
Chairman of the Board and Chief Executive Officer
|
|||||||||||
Date: | November 5, 2020 | By: | /s/ David V. Elkins | ||||||||
David V. Elkins
Chief Financial Officer
|
/s/ Giovanni Caforio, M.D. | ||
Giovanni Caforio, M.D.
Chairman of the Board and Chief Executive Officer
|
/s/ David V. Elkins | ||
David V. Elkins
Chief Financial Officer
|
/s/ Giovanni Caforio, M.D. | ||
Giovanni Caforio, M.D.
Chairman of the Board and Chief Executive Officer
|
/s/ David V. Elkins | ||
David V. Elkins
Chief Financial Officer
|